Research Assistant II

YOU ARE REQUIRED TO SUBMIT A RESUME WITH YOUR APPLICATION!

Research Assistant II - AdventHealth - Orlando

Location Address: 601 EAST ROLLINS STREET, ORLANDO, FL, 32803

Top Reasons to work at AdventHealth – Orlando

• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
• AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
• We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year

Work Hours/Shift: Monday – Friday 6:45am – 3:15pm

You Will Be Responsible For:

The Research Assistant II (RA II) will assist the Clinical Research Coordinators (CRC)/Research Nurse in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. The RA II is immediately accountable to the CRC/CRN and works with them and other study team members to meet study-specific goals and timelines and communicates appropriately and effectively with subjects, investigators, CRC’s and other staff. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:

• Develops methods to assist the CRC/CRN in screening all new patients and consults for trials. Conforms to all standards of good research practice and provide support to research patients by abiding current IRB, FDA, federal, state and institutional regulations pertaining to human subjects research, including the use of institutional and departmental SOP’s

• Delivers safe care and demonstrates regard for the dignity and respect of all participants. Practices the principles of Universal Precautions. Understands and abides by HIPAA regulations.

• The RA II will assist the CRC/CRN in coordinating and facilitating study-required activities of trial participants. Assures the consent process has been fully executed. Communicates patient events and concerns regarding the patient’s level of understanding to the CRC/CRN. Functions as a patient advocate. Provides support to and is a resource person for questions and information required by patients and families.

• Assists the CRC and CRN in maintaining neat, organized, accurate, and up-to-date source document records for all participants. Completes Case Report Forms (CRF’s) or subject tracking tools in a timely manner. Ensures that all data collection and submissions meet protocol specifications and requirements.

• Understands the protocol document and performs required activities as exhibited through collaboration with the CRC/CRN. Communicates with the CRC/CRN incoming data and patient status such as adverse events and inconsistencies.

• The RA II is responsible for accurate and timely submission or filing of data forms, angiography, echocardiology and/or laboratory materials. Abstracts and records essential physical and test data. Assists with source document completion for all required/reported data. Enters data in time frame specified. Maintains study chart to coincide with current patient status. Responds to data clarification requests (queries) in a timely manner.

• Promotes Principal Investigator (PI) oversight by advising the CRC/CRN, Supervisor or Manager of deviations in conduct, patient status, issues relevant to the integrity of the trial or the safety of research subjects. Under direction of the CRC/CRN, records and reports protocol deviations and all adverse drug reactions according to FDA, IRB, departmental and protocol guidelines within the established time periods. Assists CRC/CRN in preparation for audits conducted by the FDA and pharmaceutical representatives, as well as avails oneself during the audit/monitoring process

• The RA II is responsible for maintaining personal professional growth and contributes to the growth of team members. Maintains adequate skills in clinical competencies. Willingly participates in the orientation of new employees. Proactive in process improvement ideas.

• Maintains a clean, prepared clinical space. Performs set-up and turnover procedures in all clinical areas, per SOPs and/or Working Instructions, in a timely manner.

• Utilizes knowledge of the levels of growth, development and skills for all patients that enter department.

• The RA II will contribute to providing the highest levels of customer service by maintaining open communication with other research staff and participating in inter and/or intradepartmental discussions relevant to research. Performs other duties as assigned or directed to ensure the smooth operation of the department or section.

KNOWLEDGE AND SKILLS REQUIRED:

• Strong interpersonal skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public.

• Ability to perform clinical tasks including assisting physician, ARNP, PA, CRC and CRN with minor procedures and other study requirements, as needed.

• Ability to work independently and as a team under the direction of the CRC, Investigator, Supervisor and Clinical Operations Manager.

• Motivated, organized, and able to perform multiple tasks in a timely manner

• Basic Computer Skills: Microsoft Office applications of Word, Outlook and Internet Skills

KNOWLEDGE AND SKILLS PREFERRED:

• Assist and/or perform diagnostic procedures

• Lab Processing

• Phlebotomy

• Computer skills, particularly Microsoft Outlook, Word, Excel, Publisher, PowerPoint, Cerner, use of internet and other research tools

• Knowledge of clinical research and research regulatory environment

• Communication skills in Spanish (writing, speaking and comprehending)

EDUCATION AND EXPERIENCE REQUIRED:

• Graduate of a Medical Assistant, EMT or Paramedic program with previous clinical experience

OR

• 3 years clinical experience

OR

• 2 years clinical research experience

EDUCATION AND EXPERIENCE PREFERRED:

• Associate degree (or equivalent) in healthcare related field.

• 4 years of practical experience in a clinical research setting.

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

• BLS

• If MA - American Association of Medical Assistants (AAMA) Certification, or American Medical Technologist (AMT) Certification, or ARMA (American Registry of Medical Assistants), or NCCT (National Center for Competency Testing), or NHA (National Health Career Association)

• If EMT - Current active State of Florida EMT license

• If Paramedic - Current active State of Florida Paramedic license

LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:

• Practical Nurse
  

SUPERVISORY RESPONSIBILITIES

• N/A